FDA.reportPublic FDA data

Sectra Orthopedic Package

Primary DI
07350092810555
Brand
Sectra Orthopedic Package
Company
Sectra AB
Model
18.1
Device description
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Published
2024-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031590000SECTRA ORTHOPEDIC PACKAGESectra-Imtec AB2003-10-02LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350092810555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350092810555073500928105557350092810555

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4613235206regulatoryaffairs@sectra.com

Regulatory Flags#

DUNS number
354117848
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350092810722Sectra Orthopedic Package20.12026-09-06
07350092810654Sectra Workstation 28.12026-05-12
07350092810685Sectra Digital Pathology Module5.02026-05-12
07350092810678Sectra Orthopedic Package19.22026-03-05
07350092810616Sectra Workstation 27.22025-10-27
07350092810609Sectra Orthopedic Package19.12025-07-17
07350092810593Sectra Digital Pathology Module4.22025-04-09
07350092810579Sectra Workstation 27.12025-04-08
07350092810562Sectra Orthopedic Package18.22025-01-12
07350092810524Sectra Digital Pathology Module4.12024-10-11
07350092810531Sectra Workstation 26.22024-10-11
07350092810517Sectra Workstation26.12024-06-04
07350092810500Sectra Digital Pathology Module4.02024-05-07
07350092810494Sectra Orthopedic Package17.22024-01-02
07350092810487Sectra Digital Pathology Module3.42023-11-13
07350092810470Sectra Workstation25.22023-11-12
07350092810449Sectra Workstation25.12023-06-21
07350092810456Sectra Digital Pathology Module3.32023-06-21
07350092810463Sectra Orthopedic Package17.12023-06-21
07350092810395Sectra Calibration Unit22022-11-07

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